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Completed

NCT Number: NCT05961553

Effect of an Individual Counseling Session on Physical Activity Level of Individuals With COPD

The goal of this randomized clinical trial is to study the effect of an individual counseling session on the level of physical activity and motivation to practice physical exercise in individuals with COPD. The main question[s] it aims to answer are:

• Does a counseling session improve the level of physical activity and motivation to practice physical exercise in individuals with COPD?

Participants will perform a respiratory rehabilitation program (Control Group, CG) and a respiratory rehabilitation program and the counseling session (Experimental Group, EG).

Researchers will compare EG to CG to see if there is any difference in physical activity level and motivation to exercise between groups.

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Key information

Conditions

COPD Behavior Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Distrital da Figueira da Foz, EPE

Figueira da Foz Municipality, Coimbra District, 3094-001, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Portuguese nationality;
  • Medical diagnosis of COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD 2022);
  • Aged over 40 years.

Exclusion criteria

  • underwent recent orthopedic surgeries (<3 months);
  • Pregnant;
  • Terminal illness diagnosis (life expectancy of less than 6 months);
  • High cardiovascular risk classification for the practice of physical activity according to American College of Sports Medicine (ACSM 2018).

Treatment and study plan

Physical Activity Counseling session

Behavioral

The counseling session on physical activity was carried out individually, six weeks after starting the respiratory rehabilitation program, with an average duration of 30 minutes, based on the guidelines of the Living Well with COPD program. The main objective of the session was: to help the participant and family members to increase physical activity levels and their integration in the long term and as secondary objectives; reinforce the importance and benefits of physical activity in the management of the health condition/symptoms; plan daily/weekly moments of physical activity; define daily goals (physical activity time/sitting time) attainable for each participant; integrate family members/companions into the user's physical activity plan; clarify doubts of the user/relative about the theme.

Pulmonary Reabilitation

Other

The program comprises a hospital group exercise program, twice a week, on alternate days, for 1h30 to 2h, each session.

Primary outcomes

  1. Average Daily Steps

    Time frame: 7 days

    quantitative variable met through the daily average of the steps, using accelerometer data.

  2. Light Physical Activity

    Time frame: 7 days

    quantitative variable evaluated with the accelerometer, measured in minutes.

  3. Moderate Physical Activity

    Time frame: 7 days

    quantitative variable evaluated with the accelerometer, measured in minutes.

  4. Vigorous Physical Activity

    Time frame: 7 days

    quantitative variable evaluated with the accelerometer, measured in minutes.

  5. Sedentary Activity

    Time frame: 7 days

    quantitative variable evaluated with the accelerometer, measured in minutes.

Sponsors and collaborators

Lead sponsor

Polytechnic Institute of Porto

Other

Registry information

Official study title

Effect of an Individual Counseling Session on Physical Activity Level of Individuals With Chronic Obstructive Pulmonary Disease (COPD) - Randomized Controlled Study (RCT)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 27, 2023
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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